New OTC Inhaler on Store Shelves

OCTOBER 24, 2012

Eileen Oldfield, Associate Editor

An inhaler from Nephron Pharmaceuticals has brought an OTC asthma medication back to retail stores, filling the gap left when Primatene Mist was discontinued in 2011.
Nephron Pharmaceuticals has launched an OTC asthma inhaler intended to replace Armstrong Pharmaceuticals' Primatene Mist, which was removed from pharmacy shelves in December 2011 because it used chlorofluorocarbon (CFC) propellants, which deplete the ozone layer.

According to a press release from Nephron, its product, Asthmanefrin, was available in retail outlets beginning in late August. The inhaler contains 11.25 mg racepinephrine per 0.5 ml puff as an active ingredient. The solution is not made with CFCs or preservatives. It is available as a 10-vial starter kid that includes an atomizer and as a 30-vial refill kit.

Epinephrine inhalers, including Primatene Mist and Asthmanefrin, are not part of current clinical treatment guidelines because epinephrine is no longer considered a safe medication for treating asthma, according to several medical organizations. Those organizations include the American College of Asthma, Allergy, and Immunology; the American Association of Respiratory Care; the American Thoracic Society; and the National Association for the Medical Direction of Respiratory Care.

Adverse side effects from the use of inhaled epinephrine include increased heart rate from dilation of the heart and other organs, according to congressional testimony by Monica Kraft, MD, president of the American Thoracic Society. In older patients or patients with heart disease, overuse can lead to cardiac stress or heart attack.

A product information sheet available on Asthmanefrin’s website warns patients with heart disease, high blood pressure, thyroid disease, diabetes, or enlarged prostate glands against using the medication. It also warns patients against using the inhaler more often or at higher doses than recommended due to potential adverse effects on the heart.

The introduction of the new OTC inhaler came the month after Armstrong Pharmaceuticals announced a campaign to bring Primatene Mist back to the OTC market during a US House of Representatives Energy and Commerce Committee Energy and Power subcommittee hearing. At the time, the company estimated that it had 1 million Primatene Mist inhalers in storage that will expire in August 2013.

Primatene Mist had been removed from the market to comply with the Montreal Protocol on Substances that Deplete the Ozone Layer after public discussion by the FDA. Those discussions began in 2006, with the FDA notifying the public in November 2008 of the impending phase out. Prior to the announcement, Primatene Mist was the only asthma inhaler sold OTC and was indicated for the temporary relief of occasional mild asthma symptoms.

In addition to Primatene Mist, the FDA phased out 7 other prescription inhalers that used CFC propellants. Five of the inhalers have been taken off the market, and the remaining 2—albuterol and ipratropium, and pirbuterol—are available until December 31, 2013. Several inhalers were also reformulated to use hydrofluoroalkane (HFA) instead of CFC propellants.